1. Field of Invention
This disclosure pertains to shielding a post-surgical reconstructed nipple. More particularly, this invention pertains to an open-end nipple shield that may be easily sutured to a patient's skin surrounding a reconstructed nipple.
2. Description of the Related Art
The current preferred method for nipple reconstruction is to make small incisions on the skin of a breast that has been reconstructed either by autologous reconstruction or breast implant. The cut tissue is then elevated, and formed and shaped into a living tissue projection that mimics the natural nipple. A common incision/elevation method is the “star” dermal flap pattern, which comprises elevation of the skin flaps of the cut “star” pattern and wrapping the star “wings” around each other.
Nipple construction is the last stage of breast reconstruction and is performed when the surgeon is confident that the prior reconstruction stages have sufficiently healed and that both the contour and shape of the reconstructed breast have achieved their final acceptable symmetry.
The technical challenges of nipple reconstruction include maintaining a desirable nipple projection and leaving an inconspicuous scar. Tissue heals in response to the forces that are placed upon it and the position the tissue is in. Thus, during the post-operative stage the protection of a newly created nipple from outside forces is crucial. A newly constructed nipple is extremely sensitive to shearing and pressure forces, which may result in flattening of a nipple.
Typical prior art for shielding nipples may be found in, for example, U.S. Pat. No. 4,870,977 by Imonti (hereinafter “Imonti”), which discloses a cone-shaped nipple protector member having an outwardly-disposed flange. More recent art is found in U.S. Pat. No. 7,938,122 by Clark (hereinafter “Clark”), which discloses a nipple guard with a hollow core component, padding, and adhesive tape.
Both Imonti and Clark's devices may be appropriate for protecting a post-operative nipple under certain circumstances but do not fully address many of the collateral concerns related to the nipple healing process. For example, the earlier art by Imonti does not allow cleansing and proper medication ointment application without removal of the protector, and the slope of Imonti's cone-shaped nipple guards prevents effective cleaning by making it more difficult to insert a cleaning implement into the area around the nipple. As another example, both of the cited prior arts ordinarily use anchoring devices such as tape, which may produce allergic reactions in a patient and not adhere to skin correctly. Moreover, the devices taught by Imonti and Clark cover more skin tissue than may be necessary, thereby preventing proper air circulation on the tissue and creating constant moisture around the wound areas. In addition, Clark's device requires that the guard be changed “one to two times per day for up to sixteen weeks or longer,” rather than use one guard that may be used for the entire recovery period. See Clark, Col. 8, 1. 48-50. Requiring so many changes will either reduce average patient compliance from missed appointments, or increase the likelihood of patient error if the patient is the one responsible for changing the guard.